Diabetes Mellitis is a metabolic disorder characterized by deficiencies in insulin secretion, insulin action or both. These deficiencies result in chronic hyperglycemia. Diabetes also has a number of associated conditions including obesity and an increased risk of cardiac disorders including cardiovascular disease. Diabetes affects over 170 million people worldwide, and is expected to double in the next twenty years.
Diabetes is divided into two types known as Type 1 diabetes and Type 2 diabetes. Type 1 diabetes is an autoimmune related disorder where the immune system of the individual acts to destroy the beta cells of the pancreas. Individuals with Type 1 diabetes are generally insulin dependent. They exhibit limited insulin secretion, if any.
Type 2 diabetes is the most common form, accounting for 90 to 95% of cases. The majority of Type 2 diabetics are not insulin dependent, but exhibit insulin secretion and insulin action deficiencies leading to hyperglycemia. The hyperglycemia is often mild with symptoms difficult to recognise. As a result, many Type 2 diabetics go undiagnosed for many years. At any given time it is estimated that 10 to 15% of the population may be at risk of developing Type 2 diabetes, but are undiagnosed.
Diabetes is most commonly diagnosed based on the oral glucose tolerance test which assesses glucose handling. Individuals are given a glucose drink after overnight fasting to test their tolerance for glucose. The test takes several hours to measure responses. Unfortunately, the glucose tolerance test and fasting insulin level test suffer from a lack of sensitivity, and false positives which limit their usefulness as prognostic indicators of diabetes.
Diabetes is a significant risk factor for cardiovascular disease, increasing the risk of a cardiac event by two to three times. Despite the recognised need for diagnostic and prognostic tools for assessing the risk of an individual developing diabetes, precursor glucose handling disorders, and associated conditions such as cardiovascular disease, no simple and accurate tests are available.
It is an object of the present invention to go some way towards filling these needs and/or to at least provide the public with a useful choice.
Early diagnosis and ongoing assessments of diabetes and precursor glucose handling disorders, or any other form of dysglycemia or dysinsulinemia, are important not only for the management thereof diabetes, but also for managing associated conditions, such as cardiovascular disease. In addition to providing early detection methods for conditions, diseases associated with dysglycemia or dysinsulinemia, for example, the present invention also has broader applications including in the cardiovascular area.
Acute cardiac disorders including acute coronary syndromes (ACS) encompass a wide spectrum of cardiac ischemic events ranging from unstable angina through to acute myocardial infarction (AMI). AMI presents as the most serious of these events and therefore requires rapid and accurate diagnosis. Patients who present with two or more of the described features (a history of ischemic chest discomfort, evolutionary changes on serial electrocardiogram (ECG) traces and a rise and fall in plasma cardiac biomarkers) are clearly identified as undergoing AMI.26 However, a significant proportion of patients (40%-50%) who present with suspected AMI do not have serial changes on ECG, or typical symptoms thus placing heavy emphasis on circulating biomarker concentrations for accurate diagnosis.26,27 
Accurate early diagnosis of myocardial infarction facilitates prompt introduction of reperfusion treatment, including effective percutaneous or thrombolytic revascularisation and adjunctive anticoagulant and anti-platelet therapy. Such treatments are progressively less effective at reducing mortality and morbidity with each hour of delay in diagnosis and management.2-4 Given the need for accelerated decision-making in this clinical situation, there is a need for identification of circulating biomarkers providing an early and specific diagnosis of acute cardiac disorders, particularly AMI, for example.
Indeed current clinical guidelines highlight the importance of biomarker measurement in the identification of myocardial infarction and acute coronary syndromes.26 A number of biomarkers have been proposed for this purpose, including creatine kinase-MB (CK-MB), troponin T (TnT), troponin I (TnI) BNP, N-BNP (also known as NP-BNP), BNP signal peptide (BNP-SP) and myoglobin, but there are limitations to their use. Time to detectable or abnormal elevation of plasma cardiac biomarkers can be 6 hours (myoglobin, CK-MB) to 12 hours (TnT, TnI, BNP, N-BNP) with peak levels not occurring until 24-48 hours after onset of injury, imposing a window of delay upon precise diagnosis and treatment.1-4 Furthermore, both myoglobin and CK-MB are non-specific and can be secreted from extra-cardiac sources, especially during trauma or surgery.1 
The long term diagnostic/predictive powers of the known markers therefore lack the accompanying power of a specific marker providing early specific diagnosis of acute cardiac disorders such as acute cardiac injury within the first few hours of clinical presentation. A need thereof still exists for early markers.
It is a further object of the present invention to provide an early marker of acute cardiac disorders, and/or to at least provide the public with a useful choice.